A US-based generic drug manufacturer reached out to Freyr for the support in ANDA submissions as per the US FDA requirements. The client required quality submissions in swift timelines. As part of the reviewing process, Freyr encountered various challenges in terms of content issues, eCTD incompatible documents and last-minute changes in the data.
Download the case study to know how Freyr helped the client achieve all ANDA submission objectives by successfully coordinating the publishing and submission activities from start to finish in a short period.
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